The Potential of Theralase®'s Anti-Cancer Therapy ("ACT")

There are an estimated 24,000 new cases of malignant gliomas diagnosed in the US annually, with more than 14,000 deaths.

In the majority of cases, they recur following initial treatment, especially for GBM, the most common and lethal form of brain cancer.

Most patients do not survive beyond 2 years, post diagnosis.³

TLD-1433 continues to advance preclinically and clinically in the destruction of new oncology targets.

In preclinical trials, TLD-1433, when activated by radiation therapy has been demonstrated to be effective in the destruction of human GBM cancer cells.

In a 2017, Company news release, Dr. Pavel Kaspler, PhD, Theralase® Research Scientist stated that, “Radiation therapy followed by NIR laser light activation of TLD-1433 is a new and unexpected discovery by the members of our research team under the leadership of Dr. Arkady Mandel and Dr. Lothar Lilge. This discovery has far reaching implications, including: targeting cancers that are difficult, if not impossible to reach with conventional laser light sources, such as GBM brain tumours or deep tissue related cancers.”

Advantages of TLD-1433:

1. Stable under radiation activation remains able to produce Reactive Oxygen Species ("ROS") via subsequent Near Infrared ("NIR") laser light activation
2. Able to be activated by radiation eliciting a PDT-like cell kill
3. Able to be dually activated (radiation followed by NIR laser) delivering a cell kill greater than the two technologies applied separately
4. Able to destroy cancer cells predominantly via Immunogenic Cell Death ("ICD") at 24 hours post treatment.
5. Able to deliver noticeable damage to tumours when radiation activated
6. Able to deliver significant tumour damage when dually activated (radiation followed by NIR laser) in the presence of transferrin

A list of select scientific publications that give a robust overview of the effects of TLD-1433 and Rutherrin® seen in preclinical and clinical models is provided in our Research section.

Lung cancer is by far the leading cause of cancer death among both men and women.

Out of all types of lung cancer, NSCLC accounts for 80 to 85% of cases.⁴

The American Cancer Society’s estimates for lung cancer in the United States for 2020 are:

• About 228,820 new cases of lung cancer (116,300 in men and 112,520 in women)
• About 135,720 deaths from lung cancer (72,500 in men and 63,220 in women)⁵

Each type of NSCLC has different kinds of cancer cells. The cancer cells of each type grow and spread in different ways. The types of NSCLC are named for the kinds of cells found in the cancer and how the cells look under a microscope:

1. Squamous cell carcinoma:Cancer that begins in squamous cells, which are thin, flat cells that look like fish scales, also called epidermoid carcinoma.
2. Large cell carcinoma: Cancer that may begin in several types of large cells.
3. Adenocarcinoma:Cancer that begins in the cells that line the alveoli and produce substances such as mucus.

In preclinical experimentation by Theralase®, an evaluation of the Transferrin Receptors (“TfRs”) by flow cytometry analysis in three human cancer cell lines; specifically: H2170 (lung squamous cell carcinoma), H460 (large cell lung cancer carcinoma) and A549 (lung adeno carcinoma) showed almost 100% of lung cancer cells express TfRs.

The preclinical in-vitro and in-vivo data demonstrates that Rutherrin® based therapy may be highly effective in the selective destruction of lung cancer tumours, with no impact to healthy tissue.

A list of scientific publications that give an overview of the effects of TLD-1433 and Rutherrin® seen in pre-clinical and clinical models is provided in our Research area.

Theralase® executed a Sponsored Research Agreement (“SRA”) with the University of Manitoba (“UM”) Medical Microbiology department in 3Q2020 to commence development of a coronavirus vaccine utilizing Theralase®’s patented and proprietary PDCs. The primary objective of the SRA was to investigate the efficacy of Theralase®’s lead PDC to destroy a variety of viruses; including: H1N1 Influenza, Zika and coronaviruses (Biological Safety Level (“BSL”) 2). The secondary objective was to optimize the concentration of PDC required, the activation methodology and how to potentially administer the treatment to humans to be used as a vaccine (prevention of a patient from contracting COVID-19) (BSL-3).

The Company’s PDC technology was effective in the destruction of Influenza and Zika viruses at low nanomolar concentrations and were expanded to include coronavirus (BSL-2).

In April 2021, Theralase® executed a Collaborative Research Agreement (“CRA”) with the National Microbiology Laboratory, Public Health Agency of Canada (“PHAC”) for the research and development of a Canadian-based SARS-CoV-2 (“COVID-19”) vaccine. Under the terms of the agreement, Theralase® and PHAC are collaborating on the development and optimization of a Theralase® COVID-19 vaccine by treating the SARS-CoV-2 virus grown on cell lines with Theralase®’s patented PDC and then light activating it with Theralase®’s proprietary TLC-3000A light technology to inactivate the virus and create the fundamental building blocks of a COVID-19 vaccine. This inactivated virus would then be purified and used to inoculate naive animals followed by challenge with the SARS-CoV-2 virus, to ascertain the efficacy of the vaccine. The project is entitled, “Photo Dynamic Compound Inactivation of SARS-CoV-2 Vaccine” and commenced in mid-April 2021.